MAUDE Adverse Event Report: DEPUY IRELAND ATTUNE PS FEM RT SZ 5 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number	150410225
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event provided 4468987 was not valid, the full udi is currently not available.
Event or Problem Description
It was reported that there was some sort of debris found inside of the sterile packaging of the implant.A different implant was used.This implant never made it on to the field and its sterile packaging was never broken.There was no surgical delay.There was not any patient harm/consequence related to the event.Doe: (b)(6) 2025.Affected side: right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: b5.Corrected: h6 health effect (clinical and impact code).If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Event or Problem Description
Additional information was received and states that: there was no patient harm/consequence related to the event.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information that has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11 additional narrative: added: d9.If information that was not available for the initial report is obtained, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : it was reported that there was some sort of debris found inside of the sterile packaging of the implant.Dr opted for a different implant.This implant never made it on to the field and its sterile packaging was never broken.There was no surgical delay.Photo was provided for review.(b)(4).The photo investigation revealed a foreign material inside the blister packaging on the white foam of the attune ps fem rt sz 5 nar cem.The observed condition of the device has been addressed through the j&j medtech orthopedic quality management system.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune ps fem rt sz 5 nar cem would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : nr was created to address current complaint condition.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary it was reported that there was some sort of debris found inside of the sterile packaging of the implant.Dr opted for a different implant.This implant never made it on to the field and its sterile packaging was never broken.There was no surgical delay.The product was returned to j&j medtech orthopaedics for evaluation.The product was returned to j&j medtech orthopaedics for evaluation.The complaint unit was forwarded to the manufacturing site j&j medtech cork.Visual inspection of the returned device found that a foreign material was present within the packaging of the attune ps fem rt sz 5 nar cem.Based on the manufacturing investigation, foreign material (nutshell) confirmed to be nutshell media used in process.Man is the assignable cause for this nonconformance.The observed condition of the device has been addressed through the j&j medtech orthopedic quality management system.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune ps fem rt sz 5 nar cem would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through j&j medtech orthopaedics quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot nr was created to address current complaint condition.Corrected: h3.

• Brand Name: ATTUNE PS FEM RT SZ 5 NAR CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 21872003
• Report Number: 1818910-2025-05953
• Device Sequence Number: 7719075
• Product Code: JWH
• UDI-Device Identifier: 10603295041849
• UDI-Public: (01)10603295041849
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 150410225
• Device Lot Number: 4468987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 04/22/2025; 05/19/2025; 06/11/2025; 06/13/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/25/2025; 05/27/2025; 06/12/2025; 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female